Game-Based Learning Intervention for Health Behaviors

(UTC Trial)

Recruiting at 2 trial locations

Overseen By Brittany Rosen, PhD, MeD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Unable to read and speak English

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 8 hours total

1400 Participants Needed

Trial Summary

What is the purpose of this trial?

The study aims to implement Using the Connect (UTC), an innovative, game-based intervention designed to increase protective factors and decrease adolescent pregnancies. This intervention will be implemented in Texas middle schools and community-based organizations. The long-term goal is to promote optimal health in youth and prevent adolescent pregnancy in populations disproportionately impacted by adolescent pregnancy and sexually transmitted infection (STI) rates. The short-term objective is to conduct a robust, multi-site clustered randomized controlled trial to evaluate implementation outcomes and the impact of UTC, a novel theory-based game developed using powerful and effective human-centered design (HCD) strategies, on intention to delay sexual activity.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What data supports the idea that Game-Based Learning Intervention for Health Behaviors is an effective treatment?

The available research shows that game-based learning interventions can be effective in improving health-related knowledge and behaviors. For example, a study on board games found a large effect on health knowledge and a small-to-moderate effect on behaviors. Another study showed that an online team-based game helped improve blood glucose control in veterans with type 2 diabetes. These findings suggest that game-based learning can be a useful tool for improving health outcomes. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Using the Connect, Using the Connect, UTC?

Research shows that game-based learning, like board games, can improve health-related knowledge and behaviors. A meta-analysis found that such games have a large effect on increasing health knowledge and a moderate effect on changing behaviors, suggesting that similar game-based interventions could be effective for health behavior changes. ^{1 2 3 4 5}

What safety data exists for the Game-Based Learning Intervention for Health Behaviors?

The provided research does not directly address safety data for the Game-Based Learning Intervention for Health Behaviors or its alternative names like Using the Connect (UTC). The studies focus on adverse event reporting systems, particularly in the context of vaccines and medications, but do not mention game-based learning interventions. Therefore, no specific safety data for this treatment is available in the provided research. ^{6 7 8 9 10}

Is the treatment 'Using the Connect' a promising treatment for health behaviors?

Yes, game-based learning, like 'Using the Connect', shows promise in promoting health behaviors. Games can make learning about health more engaging and fun, which can motivate people to change their habits. They connect with people's everyday lives and can be especially effective for those who might not be interested in traditional health education. ^{11 12 13 14 15}

How does the Game-Based Learning Intervention for Health Behaviors differ from other treatments?

The Game-Based Learning Intervention, Using the Connect, is unique because it uses game-based approaches like serious games and gamification to promote health behavior change, making it more engaging and motivating compared to traditional treatments. This approach is particularly effective for reaching and engaging target groups that are typically difficult to reach or disinterested in conventional health interventions. ^{11 12 13 14 15}

Research Team

Brittany Rosen, PhD, MEd

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

This trial is for middle school-aged youth in Texas who can read and complete surveys in English without help. They must be at one of the participating schools or community organizations. It's not open to those who cannot read and speak English.

Inclusion Criteria

I am a middle school student at a participating site in Texas.

Ability to complete Using the Connect in English

Ability to read and complete surveys in English without assistance

Exclusion Criteria

I cannot read or speak English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete validated surveys prior to participating in the treatment or control group

1 week

1 visit (in-person or virtual)

Treatment

Participants engage in the Using the Connect (UTC) game-based intervention, consisting of four games and a take-away activity

8 hours total

Multiple sessions (in-person)

Immediate Post-Assessment

Participants complete surveys immediately after participating in the treatment or control group

1 week

1 visit (in-person or virtual)

Follow-up

Participants are monitored for changes in intention to delay sexual intercourse at 3-month and 9-month follow-up surveys

9 months

2 visits (in-person or virtual)

Treatment Details

Interventions

• Using the Connect

Trial Overview The study tests 'Using the Connect' (UTC), a game-based intervention aimed at increasing protective factors against adolescent pregnancy and STI rates by encouraging youths to delay sexual activity.

Participant Groups

Group I: Using the Connect Experimental Treatment 1 Intervention

Using The Connect (UTC) is a game-based learning program designed for middle school-aged youth (ages 9-15 or grades 6-8) consisting of four games played in a facilitated environment, and one take-away activity. The goals of the program include:To be a vehicle that encourages community sharing of healthy teen behavior. To facilitate safe connections between youth and adults in their community. To empower youth to lead healthy sexual lives. The four games each focus on specific health content or skills including growth and development, accessing information, positive communication, and decision-making. Each of the four games is intended to be played for a total of 90 minutes, split up into sessions of 30 minutes per game. When combining all gameplay sessions, along with the instructions for the take-away activity and program wrap-up activity, organizations will dedicate approximately 8 hours to the program.

Group II: Business as Usual Active Control 1 Intervention

Participants will not receive the Using the Connect curriculum.

Using the Connect is already approved in United States for the following indications:

Approved in United States as Using the Connect for:

• Adolescent pregnancy prevention
• Sexually transmitted infection (STI) prevention

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Texas A&M University

Collaborator

Trials

156

Recruited

28,900+

Findings from Research

The game-based learning intervention, Tapamole, achieved a 100% sensitivity in recognizing melanoma features, outperforming the pamphlet group's 95%, indicating its effectiveness in education.

Both the game and pamphlet interventions showed similar specificity and accuracy, but participants found the game more enjoyable, suggesting that engaging educational tools can enhance learning experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online, game-based education for melanoma recognition: A pilot study. Maganty, N., Ilyas, M., Zhang, N., et al.[2019]

The analogue game tested in group-based diabetes education significantly enhanced person-centredness and peer dialogues, with 92% of participants and 94% of professionals affirming its effectiveness.

The game fostered a playful atmosphere and active engagement, leading to valuable reflections and insights into the needs of people with diabetes, as reported by both participants and healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing an analogue game to promote peer support and person-centredness in education for people with diabetes: A realist evaluation. Stenov, V., Lindgreen, P., Willaing, I., et al.[2021]

Nondigital board games have a significant positive impact on health-related knowledge, with a large effect size (d* = 0.82) based on a systematic review of 21 studies involving a total of 6554 participants.

The use of board games also shows small-to-moderate effects on health behaviors (d* = 0.33) and biological health indicators (d* = 0.37), suggesting they can be effective tools for improving various health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Board Games for Health: A Systematic Literature Review and Meta-Analysis. Gauthier, A., Kato, PM., Bul, KCM., et al.[2019]

A study involving 456 patients with diabetes showed that an online game designed for diabetes self-management education (DSME) led to significant reductions in hemoglobin A1c (HbA1c) levels over 12 months, outperforming a civics game.

Patients with higher baseline HbA1c levels (>75 mmol/mol) experienced even greater improvements, with reductions comparable to starting a new diabetes medication, suggesting that online games can be an effective and scalable method for managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Team-Based Online Game Improves Blood Glucose Control in Veterans With Type 2 Diabetes: A Randomized Controlled Trial. Kerfoot, BP., Gagnon, DR., McMahon, GT., et al.[2022]

Teaching self-management skills through engaging methods, like serious games, is more effective for improving health outcomes in patients with chronic illnesses than just providing information or technical skills.

The eSMART-HD game was specifically designed to enhance interactions between patients with chronic disorders and their healthcare providers, aiming to support learning and promote health-related behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CREATING A SERIOUS GAME FOR HEALTH. Clochesy, JM., Buchner, M., Hickman, RL., et al.[2015]

In a study involving 153 employees, 42% participated in testing an app designed for reporting adverse events following immunization (AEFI), with 63% of users rating the experience positively, indicating good acceptance of the app-based technology.

Concerns about data protection were the main reason for declining participation, suggesting that improving data security measures could enhance the acceptability and effectiveness of app-based AEFI reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. Nguyen, MTH., Ott, JJ., Caputo, M., et al.[2020]

A study involving 31 health professionals revealed significant gaps in knowledge and fear of punishment as major barriers to effectively reporting adverse events in a teaching hospital.

Improving communication and educational practices between leaders and healthcare professionals is essential to enhance the reporting of adverse events, which is crucial for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The practice of reporting adverse events in a teaching hospital. Siman, AG., Cunha, SGS., Brito, MJM.[2019]

Providing numeric information about the likelihood of adverse events (AEs) in medications improves risk comprehension among consumers, as shown in a survey of 905 participants, where those given numeric formats were less likely to overestimate risks.

While numeric formats generally increased willingness to use medications, older adults with lower numeracy skills showed less change in their willingness, suggesting that while numeric information is beneficial, its impact may vary by age and numeracy level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Numbers matter to informed patient choices: a randomized design across age and numeracy levels. Peters, E., Hart, PS., Tusler, M., et al.[2022]

In a study of 22,056 acute care encounters for children aged 2 to 17, only 1.5% had reported safety events, highlighting the low rate of adverse event reporting in this setting.

The study found that obesity and African American race were negatively associated with safety event reporting, suggesting potential biases in voluntary event reporting systems that may overlook certain demographic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Characteristics Associated With Voluntary Safety Event Reporting in the Acute Care Setting. Thurtle, DP., Daffron, SB., Halvorson, EE.[2020]

In 2001, there were approximately 4.3 million visits to healthcare facilities in the U.S. due to adverse drug events (VADEs), indicating a significant patient safety concern.

The study found that VADEs were more common in elderly patients aged 65-74 and in females, highlighting the need for targeted safety measures in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory care visits for treating adverse drug effects in the United States, 1995-2001. Zhan, C., Arispe, I., Kelley, E., et al.[2019]

The Food Game intervention successfully engaged high school students in Northern Italy through gamification, promoting peer-led activities and competition, although it did not significantly change adherence to the Mediterranean diet.

While there was no notable improvement in dietary adherence, students showed increased pro-environmental behaviors and positive attitudes towards healthy eating, suggesting the program's potential as a motivational strategy for promoting healthier lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Process Evaluation of Food Game: A Gamified School-Based Intervention to Promote Healthier and More Sustainable Dietary Choices. Aresi, G., Giampaolo, M., Chiavegatti, B., et al.[2023]

The redesigned Schisto and Ladders game significantly increased children's awareness of praziquantel treatment, with 67.9% of participants in the intervention group knowing about it after playing, compared to only 1.1% in the control group.

The game also effectively encouraged treatment compliance, as 65.3% of children in the intervention group sought praziquantel treatment after the trial, demonstrating its potential as a health education tool in schools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Schisto and Ladders version 2: a health educational board game to support compliance with school-based mass drug administration with praziquantel - a pilot study. Ejike, CU., Oluwole, AS., Omitola, OO., et al.[2021]

Digital game-based approaches, including serious games and gamification, can effectively promote health-related information and encourage behavior change, particularly among hard-to-reach audiences.

These playful applications leverage game design elements to enhance motivation and engagement, making them valuable tools in health promotion and training for health professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Game-based approaches to prevention and health promotion: serious games and gamification]. Tolks, D., Lampert, C., Dadaczynski, K., et al.[2021]

Many health-related games lack proper validation and research studies often have poor design, making their efficacy uncertain.

The paper suggests guidelines for conducting high-quality studies to better evaluate the effectiveness of games for health, drawing on lessons from digital game-based learning in education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating Efficacy and Validating Games for Health. Kato, PM.[2015]

A scoping review of 22 publications on nutrition education games found that while most studies reported positive outcomes in dietary behavior change and knowledge, the overall quality of research was poor, limiting the ability to conduct a meta-analysis.

The review highlights the need for more rigorous research to better evaluate the effectiveness of these games in promoting healthy dietary behaviors, as current studies show significant diversity in design and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition Education and Dietary Behavior Change Games: A Scoping Review. Baranowski, T., Ryan, C., Hoyos-Cespedes, A., et al.[2023]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Online, game-based education for melanoma recognition: A pilot study. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Testing an analogue game to promote peer support and person-centredness in education for people with diabetes: A realist evaluation. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Board Games for Health: A Systematic Literature Review and Meta-Analysis. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

A Team-Based Online Game Improves Blood Glucose Control in Veterans With Type 2 Diabetes: A Randomized Controlled Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

CREATING A SERIOUS GAME FOR HEALTH. [2015]

6. Germany pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. [2020]

7. Brazil pubmed.ncbi.nlm.nih.gov

The practice of reporting adverse events in a teaching hospital. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Numbers matter to informed patient choices: a randomized design across age and numeracy levels. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Patient Characteristics Associated With Voluntary Safety Event Reporting in the Acute Care Setting. [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Ambulatory care visits for treating adverse drug effects in the United States, 1995-2001. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Process Evaluation of Food Game: A Gamified School-Based Intervention to Promote Healthier and More Sustainable Dietary Choices. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Schisto and Ladders version 2: a health educational board game to support compliance with school-based mass drug administration with praziquantel - a pilot study. [2021]

13. Germany pubmed.ncbi.nlm.nih.gov

[Game-based approaches to prevention and health promotion: serious games and gamification]. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Evaluating Efficacy and Validating Games for Health. [2015]

15. United States pubmed.ncbi.nlm.nih.gov

Nutrition Education and Dietary Behavior Change Games: A Scoping Review. [2023]